System, device, and method for determining location of arrhythmogenic foci

ABSTRACT

A locator assembly ( 100 ) for determining a location of an arrhythmogenic foci ( 632 ) in or near a heart ( 101 ). The locator assembly ( 100 ) includes a device body ( 112 ) and a plurality of electrodes ( 102 ). The plurality of electrodes ( 102 ) receive electrical signals from the heart ( 101 ) to determine the location of the arrhythmogenic foci ( 632 ). The plurality of electrodes ( 102 ) can be coupled to the device body ( 112 ). At least two of the plurality of electrodes ( 102 ) can positioned circumferentially about the device body ( 112 ). The plurality of electrodes ( 102 ) can be positionable so that the plurality of electrodes ( 102 ) are in electrical communication with the heart ( 101 ).

RELATED APPLICATION

This continuation application claims priority on U.S. Application SerialNo. 17/505,263, filed on Oct. 19, 2021, and entitled “SYSTEM, DEVICE,AND METHOD FOR DETERMINING LOCATION OF ARRHYTHMOGENIC FOCI”. As far aspermitted, the contents of United States Application Serial No.17/505,263 are incorporated in their entirety herein by reference.

BACKGROUND

Atrial fibrillation is an irregular and sometimes rapid heart rate thatcan increase the risk of stroke, heart failure, and other heart-relatedcomplications. During atrial fibrillation, the heart’s two upperchambers (the atria) beat chaotically and irregularly — out ofcoordination with the heart’s two lower chambers (the ventricles).Atrial fibrillation symptoms often include heart palpitations, shortnessof breath, and weakness. Although atrial fibrillation usually isn’tlife-threatening, it is a severe medical condition that sometimesrequires treatment. Atrial fibrillation can originate from focal sources(referred to herein as “arrhythmogenic foci”) in the atria or otherlocations in and around the heart.

Catheter ablation of atrial fibrillation is currently performed using ananatomically-based approach to the atrial substrate. Previous modelshypothesize that most clinical atrial fibrillation episodes originateinside the pulmonary veins. Eligible patients for atrial fibrillationablation are not representative of the typical patient with atrialfibrillation (e.g., eligible patients for atrial fibrillation ablationon average are ten years younger, commonly with fewer co-morbidities).As a result, pulmonary vein isolation is unlikely to be an effectivestrategy to cure atrial fibrillation in the overall population of atrialfibrillation patients.

The anatomically-based approach to the atrial substrate surrogates theability of clinicians to provide relevant electrophysiologicalinformation during clinical episodes of atrial fibrillation. Problemswith the anatomically-based approach include (1) recurrent conductionacross the isolating ablation lesions deployed at the pulmonary veinorifice/antrum, (2) precipitation of atrial fibrillation events fromsites other than the pulmonary vein. Recurrence of atrial fibrillationevents includes many patients among those in whom pulmonary veinisolation fails to control recurrences of atrial fibrillation. In allpatients with previously successful pulmonary vein isolation, recurrentepisodes still exist.

Mapping areas alternative to pulmonary veins that generate extra beatsprecipitating atrial fibrillation episodes is currently precluded by theinability to monitor real-time precipitating episodes. Other approaches,such as a surrogate strategy to real-time mapping, are represented bycatecholamine-induced atrial fibrillation during ablation procedures.However, the surrogate strategy is not standardized, is time-consumingand ineffective (drug-induced atrial fibrillation does not representspontaneous atrial fibrillation). Another major problem is the abilityto accurately determine the precise location of the arrhythmogenic focithat is causing atrial fibrillation.

SUMMARY

The present invention is directed toward a method for locating anarrhythmogenic foci in or near a heart. In various embodiments, themethod includes the steps of positioning a locator assembly within theheart, the locator assembly including a plurality of electrodes thatreceive electrical signals from the heart, generating a first signalarray from the electrical signals received by the plurality ofelectrodes to determine an actual location of the arrhythmogenic foci,artificially stimulating the heart based on the actual locationdetermined by the first signal array to generate a second signal array,and confirming the actual location of the arrhythmogenic foci bycomparing the first signal array with the second signal array.

In some embodiments, the locator assembly includes a plurality ofbipolar electrodes.

In certain embodiments, the method further includes the step ofdisplaying the first signal array and the second signal array on agraphical user interface.

In various embodiments, the method further includes the step ofsuperimposing the first signal array and the second signal array on thegraphical user interface.

In some embodiments, the locator assembly includes an inner layer and anouter layer configured to work in cooperation to protect one or morecomponents of the locator assembly.

In certain embodiments, at least one of the inner layer and the outerlayer include an eluting drug configured to counteract a pro-thromboticand an inflammatory potential of the locator assembly.

In various embodiments, the step of positioning includes deploying thelocator assembly to a coronary sinus of the heart with a percutaneoustranscatheter.

In some embodiments, the step of positioning includes inflating aballoon to expand the locator assembly so that the locator assembly iscircumferentially in contact with a portion of the heart.

The present invention is also directed toward a method for locating anarrhythmogenic foci in or near a heart. In some embodiments, the methodincludes the steps of positioning a locator assembly within the heart,the locator assembly including a plurality of electrodes that receiveelectrical signals from the heart, generating a first signal array fromthe electrical signals received by the plurality of electrodes todetermine an actual location of the arrhythmogenic foci, artificiallystimulating the heart based on the actual location determined by thefirst signal array to generate a second signal array, and superimposingthe first signal array and the second signal array on a graphical userinterface.

In various embodiments, the locator assembly includes an expandablestent that is configured to be inserted into the heart.

In some embodiments, the locator assembly includes a plurality ofelectrodes longitudinally positioned along the locator assembly.

In certain embodiments, the locator assembly includes a plurality ofrouting layers that interconnect the plurality of electrodes, theplurality of routing layers each being stretchable and flexible.

In various embodiments, the locator assembly includes an communicatorthat is configured to allow communication between the locator assemblyand an external device.

In some embodiments, the locator assembly includes an communicator thatis configured to allow communication between the locator assembly and anexternal device.

In certain embodiments, the locator assembly includes a battery that isconfigured to (i) store power and (ii) power components of the locatorassembly.

In various embodiments, the locator assembly includes an inner diameterthat is configured to be expandable using an inflatable balloon.

In some embodiments, the locator assembly includes a plurality ofcomponents that are equally spaced about a circumference of the locatorassembly.

In certain embodiments, the locator assembly includes an inner layer andan outer layer configured to work in cooperation to protect one or morecomponents of the locator assembly.

In various embodiments, the locator assembly is configured to be movablebetween (i) a contracted state wherein the locator assembly has acontracted diameter, and (ii) an expanded state wherein the locatorassembly has an expanded diameter.

In some embodiments, a ratio of the expanded diameter to the contracteddiameter is less than 20:1 and greater than 1:1.

The present invention is also directed toward a method for locating anarrhythmogenic foci in or near a heart. In certain embodiments, themethod includes the steps of positioning a locator assembly within theheart, the locator assembly including at least 12 bipolar electrodesthat receive electrical signals from the heart, generating a firstsignal array from the electrical signals received by the plurality ofbipolar electrodes to determine an actual location of the arrhythmogenicfoci, artificially stimulating the heart based on the actual locationdetermined by the first signal array to generate a second signal array,superimposing the first signal array and the second signal array on agraphical user interface, and confirming the actual location of thearrhythmogenic foci by comparing the first signal array with the secondsignal array.

This summary is an overview of some of the teachings of the presentinvention and is not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details are found in the detaileddescription and appended claims. Other aspects will be apparent topersons skilled in the art upon reading and understanding the followingdetailed description and viewing the drawings that form a part thereof,each of which is not to be taken in a limiting sense. The scope hereinis defined by the appended claims and their legal equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of this invention, as well as the invention itself,both as to its structure and its operation, will be best understood fromthe accompanying drawings, taken in conjunction with the accompanyingdescription, in which similar reference characters refer to similarparts, and in which:

FIG. 1A is a simplified perspective view of an embodiment of a locatorassembly for locating an arrhythmogenic foci in or near a heart and anexternal device, the locator assembly having features of the presentinvention;

FIG. 1B is a simplified illustration of the heart and an embodiment ofthe locator assembly for locating the arrhythmogenic foci in or near theheart, the locator assembly being positioned within a portion of theheart;

FIG. 2A is a simplified end view of an embodiment of the locatorassembly, shown in a contracted state;

FIG. 2B is a simplified end view of an embodiment of the locatorassembly, shown in an expanded state;

FIG. 3 is a simplified, partially transparent, perspective view of anembodiment of the locator assembly showing the bipolar relationshipsbetween pairs of electrodes within the locator assembly;

FIG. 4A is a simplified end view of an embodiment of the locatorassembly;

FIG. 4B is a simplified end view of yet another embodiment of thelocator assembly;

FIG. 4C is a simplified end view of a portion of the embodiment of thelocator assembly shown in FIG. 4B;

FIG. 4D is a simplified end view of yet another portion of theembodiment of the locator assembly shown in FIG. 4B;

FIG. 5A is a simplified, partially transparent view of a portion of theheart, an embodiment of the locator assembly and an embodiment of adeployment catheter, the locator assembly being shown in the contractedstate;

FIG. 5B is a simplified, partially transparent view of a portion of theheart, an embodiment of the locator assembly and an embodiment of thedeployment catheter, the locator assembly being shown in the expandedstate;

FIG. 6 is a simplified illustration of an embodiment of the locatorassembly positioned within a portion of the heart, including a sinusrhythm foci, the arrhythmogenic foci, and a predicted foci in the heart;

FIG. 7 is a simplified diagram illustrating a sinus signal array, afirst signal array, and a second signal array generated during oneembodiment of a method for locating the arrhythmogenic foci in or nearthe heart;

FIG. 8 is a simplified diagram illustrating a superimposition of thefirst signal array and the second signal array over one anothergenerated during one embodiment of the method for locating thearrhythmogenic foci, the superimposition being shown in an unmatchedstate;

FIG. 9 is a simplified diagram illustrating a superimposition of thefirst signal array and the second signal array over one anothergenerated during an embodiment of the method for determining thelocation of the arrhythmogenic foci, the superimposition being shown ina matched state;

FIG. 10 is a flow chart outlining one embodiment of a method fordetermining the location of arrhythmogenic foci in the heart;

FIG. 11 is a flow chart outlining another embodiment of a method fordetermining the location of arrhythmogenic foci in the heart; and

FIG. 12 is a flow chart outlining yet another embodiment of a method fordetermining the location of arrhythmogenic foci in the heart.

While embodiments of the present invention are susceptible to variousmodifications and alternative forms, specifics thereof have been shownby way of example and drawings, and are described in detail herein. Itis understood, however, that the scope herein is not limited to theparticular embodiments described. On the contrary, the intention is tocover modifications, equivalents, and alternatives falling within thespirit and scope herein.

DESCRIPTION

The systems, devices, and related methods for determining the locationof arrhythmogenic foci are configured to enable mapping of precipitatingepisodes of clinical atrial fibrillation during a patient’s daily life.In particular, a locator assembly 100 can be implanted within thepatient so that the locator assembly 100 can locate the origin ofclinical atrial fibrillation in or near a heart 101 of the patient. Asused herein, the “heart” is understood to mean the heart including bothatrial chambers, both ventricular chambers, the septum, the pulmonaryveins, the coronary sinus, the fossa ovalis, the superior vena cava, theinferior vena cava, the muscular sleeves, the vascular walls, connected,electrically active tissues, and all other heart support structures inor near the heart.

The locator assembly 100 can be used in the systems and methodsdescribed herein for determining a location of an arrhythmogenic foci632 (illustrated in FIG. 6 , for example) in or near the heart 101 ofthe patient. The systems, methods, and devices for determining thelocation of the arrhythmogenic foci 632 in or near the heart 101described herein can vary.

Those of ordinary skill in the art will realize that the followingdetailed description of the present invention is illustrative only andis not intended to be in any way limiting. Other embodiments of thepresent invention will readily suggest themselves to such skilledpersons having the benefit of this disclosure. Reference will now bemade in detail to implementations of the present invention, asillustrated in the accompanying drawings.

In the interest of clarity, not all of the routine features of theimplementations described herein are shown and described. It will, ofcourse, be appreciated that in the development of any such actualimplementation, numerous implementation-specific decisions must be madein order to achieve the developer’s specific goals, such as compliancewith application-related and business-related constraints, and thatthese specific goals will vary from one implementation to another andfrom one developer to another. Moreover, it is appreciated that such adevelopment effort might be complex and time-consuming but wouldnevertheless be a routine undertaking of engineering for those ofordinary skill in the art having the benefit of this disclosure.

FIG. 1A is a simplified perspective view of an embodiment of a locatorassembly 100 for locating arrhythmogenic foci 632 (illustrated in FIG. 6) in or near the heart 101, and an external device 105. As providedherein, the locator assembly 100 is deliverable to a portion of theheart 101 of a patient. The locator assembly 100 can map precipitatingepisodes of clinical atrial fibrillation during the patient’s dailylife. The locator assembly 100 can be expandable to become anchored in aportion of the heart 101 of the patient.

In various embodiments, the locator assembly 100 can be configured toprovide cardiac telemetry monitoring and sampling ofelectrophysiological signals from the heart 101 of the patient. It isappreciated that, by providing the locator assembly 100 with telemetrycapabilities, the locator assembly 100 can be more suitable for patientswith asymptomatic, rare, or intermittent atrial fibrillation episodes.

In one embodiment, the locator assembly 100 can sample electrocardiogramsignals from the heart 101 of the patient periodically (in either evenor uneven time increments) throughout a sampling period. In someembodiments, the sampling period can be between one hour and one year.In other embodiments, the sampling period can be less than one hour orgreater than one year. The locator assembly 100 can capture anarrhythmia or an arrhythmogenic foci 632 that may not be captured duringa shorter sampling period by providing more extended sampling periods.

In certain embodiments, the locator assembly 100 is positioned andexpanded within the heart 101 of the patient. In some embodiments, thelocator assembly 100 can operate somewhat similarly to an expandablestent. The locator assembly 100 can be placed within the patientpermanently. Alternatively, the locator assembly 100 can be removed fromthe patient, such as after the locator assembly 100 runs out of storedpower, to replace or repair various components, or for any othersuitable purpose. The locator assembly 100 has a longitudinal axis 100 abut may also have other axes. The locator assembly 100 has acircumference 100 c.

In some embodiments, if the cross-section of the locator assembly 100 isa perfect circle and the longitudinal axis 100 a is perfectly centeredthrough the end of the locator assembly 100, all positions on thecircumference 100 c are equidistant from the longitudinal axis 100 a. Invarious embodiments, the locator assembly 100 and its incorporatedelements and components thereof can be rechargeable. In one embodiment,the locator assembly 100 can be wirelessly recharged while the locatorassembly 100 is positioned within the patient.

The locator assembly 100 can vary depending on its design requirements.It is understood that the locator assembly 100 can include additionalcomponents, systems, subsystems, and elements other than thosespecifically shown and/or described herein. Additionally, oralternatively, the locator assembly 100 can omit one or more of thecomponents, systems, subsystems, and elements that are specificallyshown and/or described herein. In some embodiments, various componentsof the locator assembly 100 can be positioned in a different manner thanwhat is specifically illustrated in FIG. 1A. In some embodiments, thelocator assembly 100 can have the same or a somewhat similar design to abare-metal stent, as one non-limiting, non-exclusive example.

Components of the locator assembly 100 can be configured to operate fora finite period or an average lifespan of the patient, if not longer. Ifnecessary, some or all of the components and/or elements of the locatorassembly 100 could potentially become immobilized during the extractionand/or replacement of the locator assembly 100.

In the embodiment illustrated in FIG. 1A, the locator assembly 100 caninclude a plurality of electrodes 102 (only one electrode is identified,with other electrodes shown as black dots in FIG. 1A, FIGS. 2A-2B, andFIGS. 3 4A-4D), a communicator 104, a controller 106, a routing layer108, a battery 110, and a device body 112. As used herein, the“components” of the locator assembly 100 can include the plurality ofelectrodes 102, the communicator 104, the controller 106, the routinglayer 108, and the battery 110.

In various embodiments, the locator assembly 100 can be configured foruse by the patient while the patient receives a magnetic resonanceimaging scan, or other imaging procedures. In other words, the locatorassembly 100 can have shielding and/or resistance to varying types ofexternal electromagnetic radiation. In some embodiments, the locatorassembly 100 can be automatically activated and/or powered on. Incertain embodiments, the locator assembly 100 can be manually activatedand/or powered on by the patient or a health care personnel.

As shown in FIG. 1A, the components of the locator assembly 100, such asthe electrodes 102, the communicator 104, the controller 106, therouting layer 108, and the battery 110, can be radially spaced apartfrom one another about the circumference 100 c. For example, in variousnon-exclusive embodiments, the components of the locator assembly 100can be spaced apart by 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90,120, or 180 degrees about the circumference 100 c. In other embodiments,the components of the locator assembly 100 can be spaced apart by lessthan 1 degree or some other radial spacing other than those listedherein.

The components of the locator assembly 100 can be positioned as providedabove, even if the cross-sectional shape of the locator assembly 100 issomething other than a circle. The cross-sectional shape of the locatorassembly 100 can be any suitable shape. Non-limiting, non-exclusiveexamples of the cross-sectional shape of the locator assembly 100include circular-shaped, oval-shaped, egg-shaped, pentagonal-shaped,hexagonal-shaped, heptagonal-shaped, octagonal-shaped, decagonal-shaped,or any suitable shape. The cross-sectional shape of the locator assembly100 can have any number of sides and any type of curvature.

In some embodiments, the components of the locator assembly 100 can bespaced apart substantially equidistant from each other about thecircumference 100 c. The locator assembly 100 can include a plurality ofplatforms (not shown) configured to retain corresponding components ofthe locator assembly 100 about the circumference 100 c. In otherembodiments, such as shown in FIGS. 1A 1B, the components of the locatorassembly 100 can integrate platforms configured to enable coupling tothe locator assembly 100.

The electrodes 102 record and sense electrical signals (such aselectrophysiological signals) sent from the heart 101 and nearbyportions of the body. In some embodiments, the electrodes 102 can recordthe atrial activity and related electrical impulses.

The type of electrodes 102 can vary depending on the design requirementsof the locator assembly 100. In some embodiments, the electrode 102 canbe positioned in different configurations than what is specificallyillustrated in FIG. 1A.

The electrodes 102 can include any suitable types of electrodes,including one or more electrocardiogram electrodes (as a non-limiting,non-exclusive example). The electrodes 102, when positioned in pairs,can form bipolar electrodes. The electrodes 102 can be coupled anddecoupled from the locator assembly 100 to repair or replace defectiveor otherwise inoperable electrodes 102 of the locator assembly 100. Thelocator assembly can include any suitable number of electrodes 102. Insome embodiments, such as FIG. 1A, the locator assembly 100 can include16 electrodes 102. In other embodiments, the locator assembly 100 caninclude 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, or 32electrodes 102. In certain embodiments, the locator assembly can 100 caninclude greater than 32 electrodes.

The electrodes 102 can be distributed about the circumference 100 c in apattern, either in the longitudinal and/or circumferential directions oron any suitable portion of the locator assembly 100. About thecircumference 100 c of the locator assembly 100, the electrodes 102 canbe spaced apart by 10, 20, 30, 45, 60, 72, 90, 120, or 180 degrees. Inother embodiments, the electrodes 102 can be positioned approximately 5,15, 25, 35, 40, 50, 55, 65, 70, 75, 80, 85, 95, 100, 105, 110, 115, 125,130, 135, 140, 145, 150, 155, 160, 165, 170, 175 or any other suitablespacing from one another along the circumference 100 c of the locatorassembly 100.

In some embodiments, the electrodes 102 can be distributed in a somewhatcircular, oval, cylindrical, or any suitable pattern about the locatorassembly 100. In one embodiment, the electrodes 102 can be evenly spacedapart from one another along the longitudinal axis 100 a and/or aboutthe circumference 100 c of the locator assembly 100. In alternativeembodiments, the electrodes 102 can be spaced apart from one anotheralong the longitudinal axis 100 a and/or about the circumference of thelocator assembly 100 in an uneven, asymmetrical, semi-random or randommanner.

The communicator 104 is used by the locator assembly 100 for wirelesscommunication between the locator assembly 110 and an external device105 (e.g., a computing device). Data collected by the locator assembly100 can be sent wirelessly via the communicator 104 to the externaldevice 105. In other words, the communicator 104 is configured to allowcommunication between the locator assembly 100 and the external device105. Alternatively, the communicator 104 can allow for wiredcommunication between the locator assembly 100 and the external device105.

The type of communicator 104 and/or the positioning of the communicator104 can vary depending on the design requirements of the locatorassembly 100. The communicator 104 can include any suitable wirelesscommunications device, such as a radio frequency, Bluetooth®, low energyantenna, and/or any suitable antenna as non-limiting, non-exclusiveexamples. The communicator 104 can also include any suitable wiredcommunication device, such as wire antennas, dipole antennas, monopoleantennas, loop antennas, transmission line antennas, etc. In someembodiments, the communicator 104 can be positioned differently thanwhat is specifically illustrated in FIG. 1A.

The external device 105 can communicate via the communicator 104 toenable (i) the transfer of data between the locator assembly 100 and theexternal device 105, (ii) the utilization of the memory of the externaldevice 105 to increase processing speeds of the locator assembly 100,and/or (iii) the storage of data on the external device 105 followingthe transfer of the data from the locator assembly 100 to the externaldevice 105. In some embodiments, the external device 105 can communicatewith the communicator 104 to execute a set of processing instructions onthe locator assembly 100. For example, the external device 105 cancommunicate via the communicator 104 to power the locator assembly 100on or off.

The external device 105 can vary depending on the design requirements ofthe locator assembly 100. The connection between the communicator 104and the external device 105 is merely demonstrative. The connection canindicate a wired and/or wireless connection between the locator assembly100, the communicator 104, and/or the external device 105.

The controller 106 can control the components of the locator assembly100. The controller 106 can vary depending on the design requirements ofthe locator assembly 100. In some embodiments, the controller 106 can bepositioned differently than what is specifically illustrated in FIG. 1A.

The controller 106 can include (as non-limiting, non-exclusive examples)processors, microprocessors, diodes, capacitors, power storage elements,ASICs, sensors, image elements (e.g., CMOS, CCD imaging elements),amplifiers, A/D, and D/A converters, associated differential amplifiers,buffers, microprocessors, optical collectors, transducers includingelectro-mechanical transducers, piezoelectric actuators, light-emittingelectronics which include LEDs, logic, memory, clock, and transistorsincluding active matrix switching transistors, and combinations thereof.Components within electronic devices or devices are described herein andinclude those components described herein. A component can be one ormore of any of the electronic devices described herein and/or mayinclude a photodiode, LED, TUFT, electrode, semiconductor, otherlight-collecting/detecting components, transistor, contact pad capableof contacting a device component, thin-film devices, circuit elements,control elements, microprocessors, interconnects, contact pads,capacitors, resistors, inductors, a memory element, power storageelement, antenna, logic element, buffer and/or other passive or activecomponents. A component of the locator assembly 100 may be connected toone or more contact pads as known in the art, such as metal evaporation,wire bonding, application of solids or conductive pastes, and the like.The processor within the controller 106 can process and store data fromeach of the plurality of electrodes 102.

The routing layer 108 routes the components of the locator assembly 100and/or the controller 106 to properly connect the components accordingto the design of the locator assembly 100 and/or the controller 106. Therouting layer 108 can vary depending on the design requirements of thelocator assembly 100 and/or the controller 106. In some embodiments, therouting layer 108 can be positioned differently than what isspecifically illustrated in FIG. 1A. The routing layer 108 can includewiring, substrates, and/or other circuitry that are encased in anon-conductive dielectric material.

The battery 110 stores power and provides power to the variouscomponents of the locator assembly 100. The battery 110 can varydepending on the design requirements of the locator assembly 100. Insome embodiments, the battery 110 can be positioned differently thanwhat is specifically illustrated in FIG. 1A.

The battery 110 can be single-use/disposable, or it can be rechargeable.The battery 110 can be any suitable battery for use within the locatorassembly 100. Non-limiting, non-exclusive examples of batteries 110 thatcan be used within the locator assembly 100 include alkaline, lithium,lithium-ion, lithium-iron-phosphate, lithium silicon, magnesium,mercury, mercury-oxide, silver-oxide, silver-zinc, zinc-air,zinc-carbon, zinc-chloride, lead, lead-acid gel, nickel-cadmium, nickeloxyhydroxide, nickel-metal hydride, nickel-zinc, and Absolyte®batteries. The battery 110 can also be a solid-state battery. Thebattery 110 can be any suitable size and/or shape for use within thelocator assembly 100, such as the partial-cylinder shape illustrated inthe embodiment shown in FIG. 1A.

In some embodiments, the battery 110 can be configured to power thelocator assembly 100 for five years or more. In certain embodiments, thebattery 110 can be configured to power the locator assembly 100 for lessthan five years. In various embodiments, the battery 110 can bewirelessly recharged. In another embodiment, the battery 110 can includea capacitor.

The device body 112 provides at least some structure for the locatorassembly 100. The device body 112 can provide a substrate to securevarious components of the locator assembly 100. The device body 112 caninclude a framework and/or a lattice structure for expansion andcontraction. In some embodiments, when the framework in the device body112 expands in circumference, a longitudinal length of the device body112 does not expand. In other embodiments, when the framework in thedevice body 112 expands in circumference, the longitudinal length of thedevice body 112 expands.

In certain embodiments, when the framework in the device body 112expands in circumference and/or longitudinal length, the electrodes 102,the communicator 104, the controller 106, the routing layer 108, and thebattery 110 also expand in circumference and/or longitudinal length.Alternatively, in some such embodiments, when the framework in thedevice body 112 contract in circumference and/or longitudinal length,the electrodes 102, the communicator 104, the controller 106, therouting layer 108, and the battery 110 also contract in circumferenceand/or longitudinal length. The various components of the locatorassembly 100 including the electrodes 102, the communicator 104, thecontroller 106, the routing layer 108, and the battery 110, can beformed by flexible and/or expandable materials.

The device body 112 can expand and contract as needed to deploy andextract the locator assembly 100 within various regions of the heart 101and body of the patient. The device body 112 can vary depending on thedesign requirements of the locator assembly 100. In some embodiments,the device body 112 can be configured differently than what isspecifically illustrated in FIG. 1A. The device body 112 can be anysuitable structure known in the art that only allows expansion andcontraction in circumference. The cross-sectional shape of the devicebody 112 in the contracted state and the expanded state can vary.Non-limiting, non-exclusive examples of the cross-sectional shape of thedevice body 112 include circular-shaped, oval-shaped, egg-shaped,pentagonal-shaped, hexagonal-shaped, heptagonal-shaped,octagonal-shaped, decagonal-shaped, or any suitable shape.

FIG. 1B is a simplified illustration of the heart 101 and an embodimentof the locator assembly 100 positioned within the heart 101. The heart101 includes a right atrium 101 a and a left atrium 101 b. As shown, thelocator assembly 100 can be flexible to conform to portions of the heart101 such as valves, veins, sinuses, etc. In particular, in theembodiment shown in FIG. 1B, the locator assembly 100 can be positionedin a coronary sinus 127 near a vena cordis media 128. However, it isunderstood that the locator assembly 100 can equally be positioned inother locations in or around the heart 101.

FIG. 2A is a simplified front elevation view of an embodiment of thelocator assembly 200 being shown in a contracted state. As used herein,the “contracted state” is understood to mean the locator assembly 200and/or the device body 212 is contracted or unexpanded. In thecontracted state, the structures and/or components, including theelectrodes 202, the communicator 204, the controller 206, the routinglayer 208, and the battery 210 within the locator assembly 200, can beat least partially contracted. For example, in one embodiment of thelocator assembly 200 shown in FIG. 2A, the device body 212 is in thecontracted state when the framework in the device body 212 is contractedor unexpanded. For ease of understanding, the contracted state of thedevice body 212 in FIG. 2A is exaggerated to demonstrate the flexibilityand/or contraction of the device body 212.

In the embodiment shown in FIG. 2A, the device body 212 is the onlycomponent shown to be in the contracted state. While in the contractedstate, the locator assembly 200 has a contracted diameter 214. In someembodiments, the contracted diameter 214 illustrated and describedherein can be between approximately 0.01 mm and 20.00 mm. In variousnon-exclusive embodiments, the contracted diameter 214 can beapproximately 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm,0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm,1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm,2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.1 mm, 3.2 mm, 3.3 mm,3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4 mm, 4.1 mm, 4.2 mm,4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, 5 mm, 5.1 mm,5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm, 6 mm,6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm,7 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm,7.9 mm, 8 mm, 8.1 mm, 8.2 mm, 8.3 mm, 8.4 mm, 8.5 mm, 8.6 mm, 8.7 mm,8.8 mm, 8.9 mm, 9 mm, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm,9.7 mm, 9.8 mm, 9.9 mm, 10 mm, 10.1 mm, 10.2 mm, 10.3 mm, 10.4 mm, 10.5mm, 10.6 mm, 10.7 mm, 10.8 mm, 10.9 mm, 11 mm, 11.1 mm, 11.2 mm, 11.3mm, 11.4 mm, 11.5 mm, 11.6 mm, 11.7 mm, 11.8 mm, 11.9 mm, 12 mm, 12.1mm, 12.2 mm, 12.3 mm, 12.4 mm, 12.5 mm, 12.6 mm, 12.7 mm, 12.8 mm, 12.9mm, 13 mm, 13.1 mm, 13.2 mm, 13.3 mm, 13.4 mm, 13.5 mm, 13.6 mm, 13.7mm, 13.8 mm, 13.9 mm, 14 mm, 14.1 mm, 14.2 mm, 14.3 mm, 14.4 mm, 14.5mm, 14.6 mm, 14.7 mm, 14.8 mm, 14.9 mm, 15 mm, 15.1 mm, 15.2 mm, 15.3mm, 15.4 mm, 15.5 mm, 15.6 mm, 15.7 mm, 15.8 mm, 15.9 mm, 16 mm, 16.1mm, 16.2 mm, 16.3 mm, 16.4 mm, 16.5 mm, 16.6 mm, 16.7 mm, 16.8 mm, 16.9mm, 17 mm, 17.1 mm, 17.2 mm, 17.3 mm, 17.4 mm, 17.5 mm, 17.6 mm, 17.7mm, 17.8 mm, 17.9 mm, 18 mm, 18.1 mm, 18.2 mm, 18.3 mm, 18.4 mm, 18.5mm, 18.6 mm, 18.7 mm, 18.8 mm, 18.9 mm, 19 mm, 19.1 mm, 19.2 mm, 19.3mm, 19.4 mm, 19.5 mm, 19.6 mm, 19.7 mm, 19.8 mm, 19.9 mm, or 20 mm. Inother embodiments, the contracted diameter 214 can be less thanapproximately 0.01 mm or greater than approximately 20.00 mm.

FIG. 2B is a simplified front elevation view of an embodiment of thelocator assembly 200 being shown in an expanded state. As used herein,the “expanded state” is understood to mean the locator assembly 200and/or the device body 212 is expanded outwardly from the contractedstate so that the locator assembly 200 and/or the device body 212 has anincreased circumference. The locator assembly 200 is movable between thecontracted state and the expanded state.

While in the expanded state, the locator assembly 200 has an expandeddiameter 216 that is greater than the contracted diameter 214. In someembodiments, the expanded diameter 216 illustrated and described hereincan be between approximately 0.01 mm and 20.00 mm. In variousnon-exclusive embodiments, the expanded diameter 216 can beapproximately 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm,0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm,1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm,2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.1 mm, 3.2 mm, 3.3 mm,3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4 mm, 4.1 mm, 4.2 mm,4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, 5 mm, 5.1 mm,5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm, 6 mm,6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm,7 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm,7.9 mm, 8 mm, 8.1 mm, 8.2 mm, 8.3 mm, 8.4 mm, 8.5 mm, 8.6 mm, 8.7 mm,8.8 mm, 8.9 mm, 9 mm, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm,9.7 mm, 9.8 mm, 9.9 mm, 10 mm, 10.1 mm, 10.2 mm, 10.3 mm, 10.4 mm, 10.5mm, 10.6 mm, 10.7 mm, 10.8 mm, 10.9 mm, 11 mm, 11.1 mm, 11.2 mm, 11.3mm, 11.4 mm, 11.5 mm, 11.6 mm, 11.7 mm, 11.8 mm, 11.9 mm, 12 mm, 12.1mm, 12.2 mm, 12.3 mm, 12.4 mm, 12.5 mm, 12.6 mm, 12.7 mm, 12.8 mm, 12.9mm, 13 mm, 13.1 mm, 13.2 mm, 13.3 mm, 13.4 mm, 13.5 mm, 13.6 mm, 13.7mm, 13.8 mm, 13.9 mm, 14 mm, 14.1 mm, 14.2 mm, 14.3 mm, 14.4 mm, 14.5mm, 14.6 mm, 14.7 mm, 14.8 mm, 14.9 mm, 15 mm, 15.1 mm, 15.2 mm, 15.3mm, 15.4 mm, 15.5 mm, 15.6 mm, 15.7 mm, 15.8 mm, 15.9 mm, 16 mm, 16.1mm, 16.2 mm, 16.3 mm, 16.4 mm, 16.5 mm, 16.6 mm, 16.7 mm, 16.8 mm, 16.9mm, 17 mm, 17.1 mm, 17.2 mm, 17.3 mm, 17.4 mm, 17.5 mm, 17.6 mm, 17.7mm, 17.8 mm, 17.9 mm, 18 mm, 18.1 mm, 18.2 mm, 18.3 mm, 18.4 mm, 18.5mm, 18.6 mm, 18.7 mm, 18.8 mm, 18.9 mm, 19 mm, 19.1 mm, 19.2 mm, 19.3mm, 19.4 mm, 19.5 mm, 19.6 mm, 19.7 mm, 19.8 mm, 19.9 mm, or 20 mm. Inother embodiments, the expanded diameter 216 can be less thanapproximately 0.01 mm or greater than approximately 20.00 mm.

In certain embodiments, a ratio of the expanded diameter 216 to thecontracted diameter 214 for the locator assembly 200 herein can bebetween approximately 1:1 and 20:1. In some such non-exclusiveembodiments, the ratio of the expanded diameter 216 to the contracteddiameter 214 for the locator assembly 200 can be approximately 1:1,1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1, 1.6:1, 1.7:1, 1.8:1, 1.9:1, 2:1,2.1:1, 2.2:1, 2.3:1, 2.4:1, 2.5:1, 2.6:1, 2.7:1, 2.8:1, 2.9:1, 3:1,3.1:1, 3.2:1, 3.3:1, 3.4:1, 3.5:1, 3.6:1, 3.7:1, 3.8:1, 3.9:1,4:1,4.1:1, 4.2:1, 4.3:1, 4.4:1, 4.5:1, 4.6:1, 4.7:1, 4.8:1, 4.9:1, 5:1,5.1:1, 5.2:1, 5.3:1, 5.4:1, 5.5:1, 5.6:1, 5.7:1, 5.8:1, 5.9:1, 6:1,6.1:1, 6.2:1, 6.3:1, 6.4:1, 6.5:1, 6.6:1, 6.7:1, 6.8:1, 6.9:1, 7:1,7.1:1,7.2:1, 7.3:1, 7.4:1, 7.5:1, 7.6:1, 7.7:1, 7.8:1, 7.9:1, 8:1,8.1:1,8.2:1, 8.3:1, 8.4:1, 8.5:1, 8.6:1, 8.7:1, 8.8:1, 8.9:1, 9:1, 9.1:1,9.2:1, 9.3:1, 9.4:1, 9.5:1, 9.6:1, 9.7:1, 9.8:1, 9.9:1, 10:1, 10.1:1,10.2:1, 10.3:1, 10.4:1, 10.5:1, 10.6:1, 10.7:1, 10.8:1, 10.9:1, 11:1,11.1:1, 11.2:1, 11.3:1, 11.4:1, 11.5:1, 11.6:1, 11.7:1, 11.8:1, 11.9:1,12:1, 12.1:1, 12.2:1, 12.3:1, 12.4:1, 12.5:1, 12.6:1, 12.7:1, 12.8:1,12.9:1, 13:1, 13.1:1, 13.2:1, 13.3:1, 13.4:1, 13.5:1, 13.6:1, 13.7:1,13.8:1, 13.9:1, 14:1, 14.1:1, 14.2:1, 14.3:1, 14.4:1, 14.5:1, 14.6:1,14.7:1, 14.8:1, 14.9:1, 15:1, 15.1:1, 15.2:1, 15.3:1, 15.4:1, 15.5:1,15.6:1, 15.7:1, 15.8:1, 15.9:1, 16:1, 16.1:1, 16.2:1, 16.3:1, 16.4:1,16.5:1, 16.6:1, 16.7:1, 16.8:1, 16.9:1, 17:1, 17.1:1, 17.2:1, 17.3:1,17.4:1, 17.5:1, 17.6:1, 17.7:1, 17.8:1, 17.9:1, 18:1, 18.1:1, 18.2:1,18.3:1, 18.4:1, 18.5:1, 18.6:1, 18.7:1, 18.8:1, 18.9:1, 19:1, 19.1:1,19.2:1, 19.3:1, 19.4:1, 19.5:1, 19.6:1, 19.7:1, 19.8:1, 19.9:1, 20:1,Alternatively, in some embodiments, the ratio of the expanded diameter216 to the contracted diameter 214 for the locator assembly 200 can begreater than approximately 20:1 or less than approximately 1:1.

FIG. 3 is a simplified, partially transparent, perspective view of anembodiment of the locator assembly 300 illustrating the bipolarrelationships between electrodes 302 within the locator assembly 300. Inthe embodiment illustrated in FIG. 3 , the locator assembly 300 caninclude the device body 312 and a plurality of bipoles 318 a-bb. Theelectrodes 302 can be bipolar electrodes having a negative polarity orpositive polarity. In FIG. 3 , the bipoles 318 a-bb are illustrated asvectors that indicate bipoles of electrical current running across thelocator assembly 300 from the electrode 302 having a negative polarityto the electrode 302 having a positive polarity. The electrode 302having a negative polarity is referred to herein as a cathode, and theelectrode 302 having a positive polarity is referred to herein as ananode.

The bipoles 318 a-bb are formed between two electrical components (suchas the anode and the cathode) with opposing polarities. In the bipoles318 a-bb, the electrical current runs across the locator assembly 300between the electrical components of opposing polarities. The electrodes302 can be excited by applying a current or a voltage to produce thebipoles 318 a-bb between the anode and cathode. The current or thevoltage can be applied to the electrodes 302 by the locator assembly 300and/or the external device 105 (illustrated in FIGS. 1A 1B).

The bipoles 318 a-bb can vary depending on the design requirements ofthe locator assembly 300 and/or the electrodes 302. In some embodiments,such as illustrated in FIG. 3 , a network of bipoles 318 a-bb, includinga plurality of anodes and cathodes, are arranged on the locator assembly300. Multiple bipoles 318 a-bb or multiple bipole networks can bearranged in any suitable portion of the locator assembly 300. Thebipoles 318 a-bb can be distributed about the longitudinal axis 100 a(illustrated in FIGS. 1A 1B) in a pattern, either in the longitudinaland/or circumferential directions or about or along any other suitableaxis.

In some embodiments, the bipoles 318 a-bb can be distributed in asomewhat circular, oval, cylindrical, or any suitable pattern about thelocator assembly 300. In one embodiment, the bipoles 318 a-bb can beevenly spaced apart from one another along the longitudinal axis 100 aand/or about the circumference of the locator assembly 300. Inalternative embodiments, the bipoles 318 a-bb can be spaced apart fromone another along the longitudinal axis 300 a and/or about thecircumference of the locator assembly 300 in an uneven, semi-random, orrandom manner. While 28 bipoles 318 a-bb are displayed in the embodimentshown in FIG. 3 , it is understood that more than 28 bipoles 318 a-bb orless than 28 bipoles 318 a-bb can be utilized by the locator assembly300.

FIG. 4A is a simplified front elevation view of an embodiment of thelocator assembly 400A. In particular, in the embodiment illustrated inFIG. 4A, the locator assembly 400A includes an inner layer 420A and anouter layer 422A. The inner layer 420A and the outer layer 422A can workin cooperation to substantially enclose and/or protect the components ofthe locator assembly 400A, including the electrode 402A, thecommunicator 404A, the controller 406A, the routing layer 408A, thebattery 410A, and/or the device body 412A.

In other embodiments, the inner layer 420A can be coupled to the outerlayer 422A to fully enclose the components of the locator assembly 400A,including the electrode 402A, the communicator 404A, the controller406A, the routing layer 408A, the battery 410A, and/or the device body412A. In certain embodiments, only one layer (e.g., the inner layer 420Aor the outer layer 422A) can fully enclose the components of the locatorassembly 400A, including the electrode 402A, the communicator 404A, thecontroller 406A, the routing layer 408A, the battery 410A, and/or thedevice body 412A.

The inner layer 420A and the outer layer 422A can cooperate to improvethe protection of the patient and components of the locator assembly400A upon the deployment of the locator assembly 400A within thepatient. The inner layer 420A can provide a substantially uniformsurface to improve the protection of a deployment balloon 526(illustrated in FIGS. 5A 5B) upon contact of the inner layer 420A withthe deployment balloon 526. The outer layer 422A can reduce thelikelihood of injury upon the contact of the outer layer 422A with oneor more inner walls of portions of the heart 101 (illustrated FIG. 1B).

The inner layer 420A and/or the outer layer 422A can be in electricalcommunication with electrode 402A and the heart 101. The inner layer420A and outer layer 422A can be at least partially formed fromelectrically conductive materials. In other embodiments, the inner layer420A and/or the outer layer 422A can be formed with holes or aperturesthat are configured to allow the electrode 402A to come in directcontact with one or more inner walls of portions of the heart 101.

The inner layer 420A and/or the outer layer 422A can release an elutingdrug over a period of time to counteract the pro-thrombotic andinflammatory potential of the locator assembly 400A at its deployedlocation (for example, one deployed location is depicted in FIGS.5A-5B). In other embodiments, one or more drug-eluting layers (not shownin FIG. 4A) can be coupled to each of the inner layer 420A and/or theouter layer 422 Aso that the inner layer 420A and/or the outer layer422A are positioned between the one or more drug-eluting layers and thedevice body 412A. In certain embodiments, the inner layer 420A and/orouter layer 422A can include multiple layers, including one or moredrug-eluting layers. In various embodiments, other components of thelocator assembly 400A (such as the device body 412A) can include aneluting drug and/or one or more drug-eluting layers.

Additionally, in the embodiment displayed in FIG. 4A, the locatorassembly 400A is shown in an expanded state, where the locator assembly400A has an expanded diameter 416. While the expanded state is shown inFIG. 4A, it is appreciated that the inner layer 420A and the outer layer422A can be movable between the contracted state and the expanded state.The inner layer 420A can vary depending on the design requirements ofthe locator assembly 400A. In some embodiments, the inner layer 420A canbe positioned differently than what is specifically illustrated in FIG.4A.

The inner layer 420A can be formed from any suitable material. Incertain embodiments, the inner layer 420A can be at least partiallyformed from a lubricious material and/or a continuous material. Theinner layer 420A can be resilient, stretchable, and/or flexible. In someembodiments, the inner layer 420A can be at least partially formed froma metal, a plastic, a composite, a polymer, a coating, a biocompatiblematerial, and/or a biodegradable material. Non-limiting, non-exclusiveexamples of suitable metals that can form the inner layer 420A includeiron, magnesium, zinc, and their corresponding alloys. Non-limiting,non-exclusive examples of suitable polymers that can be used to form theinner layer 420A include polylactic acid, tyrosine polycarbonate,salicylic acid, poly-DL-lactide, and everolimus.

The inner layer 420A can include drugs to counteract the pro-thromboticand inflammatory potential of the locator assembly 400A, such asimmunosuppressive and antiproliferative drugs. Specific non-limiting,non-exclusive drugs usable within the inner layer 420A includesirolimus, paclitaxel, and everolimus. However, it is appreciated thatany suitable, elutable drug can be utilized within the inner layer 420A.

The outer layer 422A can vary depending on the design requirements ofthe locator assembly 400A. In some embodiments, the outer layer 422A canbe positioned differently than what is specifically illustrated in FIG.4A. The outer layer 422A can be formed from any suitable material. Incertain embodiments, the outer layer 422A can be at least partiallyformed from a lubricious material and/or a continuous material. Theouter layer 422A can be resilient, stretchable, and/or flexible. In someembodiments, the outer layer 422A can be at least partially from ametal, a plastic, a composite, a polymer, a coating, a biocompatiblematerial, and/or a biodegradable material. Non-limiting, non-exclusiveexamples of suitable metals that can form the outer layer 422A includeiron, magnesium, zinc, and their corresponding alloys. Non-limiting,non-exclusive examples of suitable polymers that can be used to form theouter layer 422A include polylactic acid, tyrosine polycarbonate,salicylic acid, poly-DL-lactide, and everolimus.

The outer layer 422A can include drugs to counteract the pro-thromboticand inflammatory potential of the locator assembly 400A, such asimmunosuppressive and antiproliferative drugs. Specific non-limiting,non-exclusive drugs usable within the outer layer 422A includesirolimus, paclitaxel, and everolimus. However, it is appreciated thatany suitable, elutable drug can be utilized within the outer layer 422A.

FIG. 4B is a simplified end view of yet another embodiment of thelocator assembly 400B. In particular, in the embodiment illustrated inFIG. 4B, the locator assembly 400B includes an inner layer 420B and anouter layer 422B. The inner layer 420B and the outer layer 420B can workin cooperation to substantially enclose and/or protect the components ofthe locator assembly 400B, including the electrode 402B, thecommunicator 404B, the controller 406B, the routing layer 408B, thebattery 410B, and/or the device body 412B. The locator assembly 400B,the electrode 402B, the communicator 404B, the controller 406B, therouting layer 408B, the battery 410B, the device body 412B, inner layer420B, and/or the outer layer 420B can be substantially similar to thelocator assembly 400A, the electrode 402A, the communicator 404A, thecontroller 406A, the routing layer 408A, the battery 410A, the devicebody 412A, inner layer 420A and/or the outer layer 420A described withrespect to FIG. 4A and the other embodiments described herein.

The locator assembly 400B is movable between a locked state and anunlocked state. In the embodiment illustrated in FIG. 4B, the locatorassembly 400B is shown in a locked state. In some embodiments, while thelocator assembly 400B is in an unlocked state, the outer layer 422B canbe separately deployable from the rest of the locator assembly 400B. Inother embodiments, the outer layer 422B can remain deployed at adeployment location (e.g., the location displayed in FIGS. 5A-B, 6 )while the rest of the locator assembly 400B is removed from thedeployment location. A new locator assembly 400B can be deployed andengaged within the outer layer 422B at the deployment location. Incertain embodiments, the locator assembly 400B can include a lockingassembly 480.

The locking assembly 480 can facilitate the locking and/or separating ofthe outer layer 422B with the remainder of the locator assembly 400Band/or the device body 412B. For example, the locking assembly 480enables locking and/or separation of the outer layer 422B from theremainder of the locator assembly 400B and/or the device body 412B bymechanical manipulation of the deployment catheter 524 (illustrated inFIGS. 5A 5B). The deployment catheter 524 can lock and unlock thelocking assembly 480 so that the locator assembly 400B is separatelypositionable with respect to the outer layer 422B. In other embodiments,the patient, the clinician, and/or the external device 105 (illustratedin FIGS. 1A 1B) can lock and/or unlock the locking assembly 480 withoutthe mechanical manipulation of the deployment catheter 524. For example,in some embodiments, the external device 105 can wirelessly transmit(e.g., via the communicator 404B) a locking command and/or an unlockingcommand to the locking assembly 480 in order to lock or unlock thelocking assembly 480.

The locking assembly 480 can vary depending on the design requirementsof the locator assembly 400 and/or the outer layer 422. It is understoodthat the locking assembly 480 can include additional components,systems, subsystems, and elements other than those specifically shownand/or described herein. Additionally, or alternatively, the lockingassembly 480 can omit one or more of the components, systems,subsystems, and elements that are specifically shown and/or describedherein. In some embodiments, the locking assembly 480 and the variouscomponents of the locking assembly 480 can be positioned in a differentmanner than what is specifically illustrated in FIG. 4B.

The locking assembly 480 can include a first locking mechanism 482 and asecond locking mechanism 484. The first locking mechanism 482 and thesecond locking mechanism 484 lock and/or engage each other so that theouter layer 422B is secured to the locator assembly 400B and/or thedevice body 412B. The first locking mechanism 482 can be coupled to thedevice body 412B and/or any suitable component of the locator assembly400B. The second locking mechanism 484 can be coupled to the outer layer422B and/or any suitable component of the locator assembly 400B.

While the locking assembly 480 includes two locking mechanisms in FIG.4B, it is appreciated that the locking assembly 480 can include anynumber of locking and/or engagement structures or elements that allowthe locking and/or engagement of the outer layer 422B to the locatorassembly 400B and/or the device body 412B. In some embodiments, asnon-limiting, non-exclusive examples, the first locking mechanism 482and the second locking mechanism 484 can include one or more of amale/female hookup assembly, a teeth/recess assembly, a tongue/grooveassembly, a latch, an anchor, a coupling, an interlocking shoulder, abolt, a cable, a clamp, a connector, a hook, a loop, a flangeprotrusion, a joint, a seam, a channel, a guide, a linkage, a track,and/or a tray. The first locking mechanism 482 and the second lockingmechanism 484 have been simplified for ease of understanding.

FIG. 4C is a simplified end view of a portion of the embodiment of thelocator assembly 400B shown in FIG. 4B. As shown in FIG. 4C, the locatorassembly 400B including the electrode 402B, the communicator 404B, thecontroller 406B, the routing layer 408B, the battery 410B, the devicebody 412B, the inner layer 420B, and/or the first locking mechanism 482can be selectively unlocked and/or detached from the outer layer 422Band/or the second locking mechanism 484.

FIG. 4D is a simplified end view of yet another portion of theembodiment of the locator assembly shown in FIG. 4B. As shown in FIG.4D, the outer layer 422B and/or the second locking mechanism 484 can beselectively unlocked and/or detached from the electrode 402B, thecommunicator 404B, the controller 406B, the routing layer 408B, thebattery 410B, the device body 412B, the inner layer 420B, and/or thefirst locking mechanism 482.

FIG. 5A is a simplified, transparent view of an embodiment of thelocator assembly 500 and embodiments of a deployment catheter 524, aguidewire 525, and a balloon 526. As illustrated in FIG. 5A, the locatorassembly 500 is positioned within the coronary sinus 527 of the heart101 (illustrated in FIGS. 1A 1B) near the vena cordis media 528.

The deployment catheter 524 deploys the locator assembly 500 in aportion of the heart 101. The deployment catheter 524 can deploy thelocator assembly 500 in the same or similar manner as the deploymentcatheter 524 would deploy an expandable stent. The deployment catheter524 can advance the locator assembly 500 to a target site within thecoronary sinus 527. In some embodiments (such as the embodiment shown inFIGS. 5A-5B), the target site can be near a junction between thecoronary sinus 527 and the vena cordis media 528. The target siteillustrated in FIGS. 5A-5B is merely demonstrative, and it isappreciated that the locator assembly 500 can be deployed in anysuitable position within the patient. The deployment catheter 524 candeploy the locator assembly 500 while the device is in the contractedstate, the expanded state, or between states (in FIG. 5A, the locatorassembly 500 is shown in a contracted state).

The deployment catheter 524 can vary depending on the designrequirements of the locator assembly 500. It is understood that thedeployment catheter 524 can include additional components, systems,subsystems, and elements other than those specifically shown and/ordescribed herein. Additionally, or alternatively, the deploymentcatheter 524 can omit one or more of the components, systems,subsystems, and elements that are specifically shown and/or describedherein. In particular, the deployment catheter 524 in FIGS. 5A-5B hasbeen simplified, and some elements of the deployment catheter 524 havebeen omitted for ease of understanding. In some embodiments, thedeployment catheter 524 can be positioned differently than what isspecifically illustrated in FIGS. 5A-5B.

In some embodiments, the deployment catheter 524 can be a percutaneoustranscatheter or any suitable catheter. The deployment catheter 524 caninclude a guidewire 525 and an inflatable balloon 526 (sometimesreferred to herein simply as a “balloon”). The deployment catheter 524can be configured to move over the guidewire 525.

The guidewire 525 can advance components through an opening of thedeployment catheter 524 (such as the locator assembly 500 and/or theballoon 526). The guidewire 525 can be advanced simultaneously with thedeployment catheter 524 within the body of the patient. The guidewire525 can vary depending on the design requirements of the locatorassembly 500 and/or the deployment catheter 524. In some embodiments,the guidewire 525 can be positioned differently than what isspecifically illustrated in FIGS. 5A-5B.

The balloon 526 can be coupled to the deployment catheter 524 and/or theguidewire 525. The balloon 526 can be inflatable to move the locatorassembly 500 between the contracted and expanded states. The balloon 526can be deflated and removed from the interior of the locator assembly500 after the locator assembly 500 has been moved to the contractedstate from the expanded state. The balloon 526 can also be deflated andremoved from the interior of the locator assembly 500 when the locatorassembly 500 is in between the contracted state and the expanded state.

The balloon 526 can vary depending on the design requirements of thelocator assembly 500, the deployment catheter 524, and/or the guidewire525. In some embodiments, the balloon 526 can be positioned differentlythan what is specifically illustrated in FIGS. 5A-5B. The balloon 526illustrated in FIGS. 5A-5B has been simplified for ease ofunderstanding.

FIG. 5B is a simplified, transparent view of an embodiment of thelocator assembly 500 and an embodiment of the deployment catheter 524,the guidewire 525, and the balloon 526. In the embodiment shown in FIG.5B, the locator assembly 500 is positioned within the coronary sinus 526of the heart 101 (illustrated in FIGS. 1A 1B), and the locator assembly500 is shown in an expanded state. As shown in FIG. 5B, the guidewire525 can extract the balloon 526 from the interior of the locatorassembly 500. The balloon 526 can deflate so that it can retract withinthe interior of the deployment catheter 524.

FIG. 6 is a simplified illustration of the heart 601, including theright atrium 601 a and the left atrium 601 b, and an embodiment of thelocator assembly 600 for determining the location of the arrhythmogenicfoci 632 in or near the heart 601. In FIG. 6 , the locator assembly 600is positioned within a portion of the heart 601. For ease inunderstanding, FIG. 6 displays exemplar locations of a sinus rhythm foci630, the arrhythmogenic foci 632, and a predicted foci 634 in the heart601.

The sinus rhythm foci 630 is the focal point of a normal sinus rhythm ofthe patient. In particular, in some embodiments, the sinus rhythm foci630 represents the origin of the electrical activation sequences of thenormal sinus rhythm, such as from the sino-atrial node. One example ofelectrical activation sequence signal arrays recorded by the locatorassembly 600 at the sinus rhythm foci 630 is illustrated in FIG. 7 inthe left column.

The arrhythmogenic foci 632 illustrated in FIG. 6 is representative ofone actual location of the focal point of an arrhythmia of the patient.It is appreciated that the arrhythmogenic foci 632 shown in FIG. 6 ismerely demonstrative and/or representative, and can be located anywherein and/or near the heart 601.

The predicted foci 634 in FIG. 6 represents the location of anartificial stimulation to determine and/or confirm whether the predictedfoci 634 is the same or different than the actual arrhythmogenic foci632. The predicted foci 634 and the arrhythmogenic foci 632 can belocated at the same location (referred to herein as a “matched state”)or different locations (referred to herein as an “unmatched state”), asdescribed in greater detail herein.

The artificial stimulation can be generated using any suitable deviceknown in the art, including ablation catheters, electrical stimulationand/or pace-makers, as non-exclusive examples. The artificialstimulation device can stimulate any suitable number of predicted foci634 during one operation and/or insertion of the artificial stimulationdevice into the patient. In other words, the artificial stimulationdevice can test various predicted foci 634 locations in rapidsuccession.

FIG. 7 is a simplified diagram displaying electrical signal array datacollected by the locator assembly 100 (illustrated in FIGS. 1A 1B, forexample). As shown in FIG. 7 , the signal array data collected by thebipoles 318 a-bb (illustrated in FIG. 3 ) is illustrated in descendingrows as electrical signals 719 a-bb. For example, FIG. 7 illustrates asinus signal array 731 that is collected by the locator assembly 100from the sinus rhythm foci 630 (illustrated in FIG. 6 ), a first signalarray 733 that is collected by the locator assembly 100 from thearrhythmogenic foci 632 (illustrated in FIG. 6 ), and a second signalarray 735 that is collected from the locator assembly 100 from thepredicted foci 634 (illustrated in FIG. 6 ).

FIG. 7 illustrates the sinus signal array 731, the first signal array733, and the second signal array 735 as displayed on a graphical userinterface (GUI) of the external device 105 (illustrated in FIGS. 1A 1B).It is understood that the actual display of the sinus signal array 731,the first signal array 733, and/or the second signal array 735 canappear differently than those shown in FIG. 7 and that the sinus signalarray 731, the first signal array 733 and the second signal array 735illustrated in FIG. 7 are provided as representative of one type ofdisplay for ease in understanding, and are not intended to be limitingin any manner. Any other suitable visual and/or auditory displays arecontemplated and are intended to be included as alternative embodiments.Still alternatively, a haptic response can be incorporated into thedisplay of the sinus signal array 731, the first signal array 733, andthe second signal array 735.

The sinus signal array 731 illustrates the electrical activationsequence recorded by the locator assembly 100 implanted in the coronarysinus 527 (illustrated in FIGS. 5A 5B) during the patient’s normal sinusrhythm. In particular, the sinus signal array 731 is recorded by each ofthe bipoles 318 a-bb to generate corresponding electrical signals 719a-bb in descending rows. For example, the bipole 318 a receives theelectrical signal 719 a from the sinus rhythm foci 630 during thepatient’s normal sinus rhythm, which is then displayed in the first rowof the sinus signal array 731. Each additional bipole 318 b-318 bblikewise receives the corresponding electrical signal 319 b-319 bb,which are likewise displayed in subsequent rows in the sinus signalarray 731.

The sinus signal array 731 can be used for a comparative assessment ofthe different sequences between the two sources of a cardiac impulseorigin. In particular, the sinus signal array 731 can represent thepatient’s electrical activation sequence of the sinus rhythm. The sinussignal array 731 can be used in comparison with the first signal array733 and/or the second signal array 735.

In the embodiment illustrated in FIG. 7 , the sinus signal array 731includes an event initiation 738A represented as a vertical straightline in the sinus signal array 731. The event initiation 738A representsthe onset of an actual event, such as an electrophysiological eventincluding an electrical signal originating from the sinus rhythm foci(or sino-atrial node), for example. It is understood that the eventinitiation 738A represents a time (such as a T₀), after which electricalsignals 719 a-bb occur.

The first signal array 733 illustrates the electrical activationsequence located at the arrhythmogenic foci 632 and recorded by thelocator assembly 100 implanted in the coronary sinus 527 during aclinical episode of atrial fibrillation of the patient. In particular,the first signal array 733 is recorded by each of the bipoles 318 a-bbto generate corresponding electrical signals 719 a-bb in descendingrows. For example, the bipole 318 a records the electrical activationsequence during a clinical episode of atrial fibrillation of thepatient, and the corresponding electrical signal 719 a is displayed inthe first row of the first signal array 733. The first signal array 733can be used in comparison with the second signal array 735, as providedin greater detail herein.

In the embodiment illustrated in FIG. 7 , the first signal array 733includes an event initiation 738B represented as a vertical straightline in the first signal array 733. The event initiation 738B representsthe initiation of an actual event, such as an electrophysiological eventincluding an electrical signal originating from the arrhythmogenic foci632, for example. It is understood that the event initiation 738Brepresents a time (such as a T₀), after which electrical signals 719a-bb occur.

The second signal array 735 illustrates the electrical activationsequence taken at the predicted foci 634 and recorded by the locatorassembly 100 implanted in the coronary sinus 527 during artificialstimulation of the patient at the predicted foci 634. In particular, thesecond signal array 735 is recorded by each of the bipoles 318 a-bb tocorresponding electrical signals 719 a-bb in descending rows. Forexample, the bipole 318 a records the electrical activation sequenceduring artificial stimulation of the patient at the predicted foci 634,and the corresponding electrical signal 719 a is displayed on the firstrow in the second signal array 735. The second signal array 735 can beused in comparison with the first signal array 733, as provided ingreater detail herein.

In the embodiment illustrated in FIG. 7 , the second signal array 735includes an event initiation 738C represented as a vertical straightline in the second signal array 735. The event initiation 738Crepresents the initiation of an actual event, such as an artificialstimulus that generates an electrical signal originating from thepredicted foci 634, for example. It is understood that the eventinitiation 738C represents a time (such as a T₀), after which electricalsignals 719 a-bb occur.

FIG. 8 is a simplified diagram illustrating a superimposition of thefirst signal array 833 and the second signal array 835 over one anothergenerated during one embodiment of the method for locating thearrhythmogenic foci 632 (illustrated in FIG. 6 ). In FIG. 8 , thesuperimposition is shown in an unmatched state. As shown in theembodiment displayed in FIG. 8 , the electrical signals 819a-bb arerecorded by the bipoles 318 a-bb (illustrated in FIG. 3 ) in descendingrows.

In the embodiment illustrated in FIG. 8 , the first signal array 833includes the event initiation 838B represented as a vertical straightline in the first signal array 833, and the second signal array 835includes the event initiation 838C represented as a vertical straightline in the second signal array 835. In this embodiment, the eventinitiations 838B, 838C are aligned so a direct comparison between thefirst signal array 833 and the second signal array 835 can be achieved.Based on the superimposition displayed in FIG. 8 , the clinician and/orthe patient can determine and/or confirm that the arrhythmogenic foci632 and the predicted foci 634 (illustrated in FIG. 6 ) are not in thesame location as one another. In this embodiment, the signal arrays 833,835 are not substantially similar or identical.

A negative sensory response can be incorporated into the locatorassembly 100 (illustrated in FIGS. 1A 1B), the deployment catheter 524(illustrated in FIGS. 5A 5B), and/or a related system in order to assistthe clinician and/or the patient in determining that the arrhythmogenicfoci 632 and the predicted foci 634 are not in the same location as oneanother (e.g., in the unmatched state). For example, in someembodiments, a negative haptic response can be incorporated into thedisplay of the signal arrays 833, 835, or into a handle (not shown) ofthe deployment catheter 524. The negative haptic response can be avibration or similar stimulation of touch and/or motion. The negativehaptic response can be included on any suitable portion of thedeployment catheter 524 or any suitable system and/or device. In otherembodiments, a negative audio response can include a beep or anysuitable audio feedback that is triggered when the superimposition is inthe unmatched state. In certain embodiments, a negative visual responsecan include a red visual indicator and/or any suitable visual indicationwhen the superimposition is in the unmatched state.

FIG. 9 is a simplified diagram illustrating a superimposition of thefirst signal array 933 and the second signal array 935 over one anothergenerated during an embodiment of the method for determining thelocation of the arrhythmogenic foci 632 (illustrated in FIG. 6 ), thesuperimposition being shown in a matched state. As shown in theembodiment displayed in FIG. 9 , the electrical signals 919 a-bb arerecorded by the bipoles 318 a-bb (illustrated in FIG. 3 ) in descendingrows.

In the embodiment illustrated in FIG. 9 , the first signal array 933includes the event initiation 938B represented as a vertical straightline in the first signal array 933, and the second signal array 935includes the event initiation 938C represented as a vertical straightline in the first signal array 935. In this embodiment, the eventinitiations 938B, 938C are aligned so a direct comparison between thefirst signal array 933 and the second signal array 935 can be achieved.Based on the superimposition displayed in FIG. 9 , the clinician and/orthe patient can determine and/or confirm that the arrhythmogenic foci632 and the predicted foci 634 (illustrated in FIG. 6 ) are in the samelocation as one another because the signal arrays 833, 835, aresubstantially similar or identical.

A positive sensory response can be incorporated into the locatorassembly 100 (illustrated in FIGS. 1A 1B), the deployment catheter 524(illustrated in FIGS. 5A 5B), and/or a related system, in order toassist the clinician and/or the patient in determining that thearrhythmogenic foci 632 and the predicted foci 634 are in the samelocation as one another (e.g., in the matched state). For example, insome embodiments, a positive haptic response can be incorporated intothe display of the signal arrays 833, 835, or into a handle (not shown)of the deployment catheter 524. The positive haptic response can be avibration or similar stimulation of touch and/or motion. The positivehaptic response can be included on any suitable portion of thedeployment catheter 524 or any suitable system and/or device. In otherembodiments, a positive audio response can include a beep or anysuitable audio feedback that is triggered when the superimposition is inthe matched state. In certain embodiments, a positive visual responsecan include a green visual indicator and/or any suitable visualindication when the superimposition is in the matched state.

FIG. 10 is a flow chart outlining one embodiment of a method fordetermining the location of arrhythmogenic foci in the heart. It isunderstood that the method pursuant to the disclosure herein can includegreater or fewer steps than those shown and described relative to FIG.10 . The method can omit one or more steps illustrated in FIG. 10 . Themethod can add additional steps not shown and described in FIG. 10 , andstill fall within the purview of the present invention. Further, thesequence of the steps can be varied from those shown and describedrelative to FIG. 10 . The sequence of steps illustrated in FIG. 10 isnot intended to limit the sequencing of steps in any manner.

In the embodiment illustrated in FIG. 10 , at step 1040, a locatorassembly is positioned within the heart. The locator assembly caninclude a plurality of electrodes that receive electrical signals fromthe heart. The locator assembly can be positioned within the heart usingany suitable method known within the art, including those describedherein. In some embodiments, the locator assembly can be positionedwithin a coronary sinus of the patient. However, other designs oflocator assemblies can be utilized by the methods described herein. Thelocator assembly can include an expandable stent that is configured tobe inserted into the heart.

At step 1042, a first signal array is generated from the electricalsignals recorded by the locator assembly to determine the actuallocation of the arrhythmogenic foci. The locator assembly can use aplurality of electrodes arranged in bipolar relationships to receive theelectrical signals. The electrical signals recorded by the plurality ofelectrodes can include atrial electrical activation signals. As usedherein, the arrhythmogenic foci can also include any focal locationwithin a human body associated with the development of perpetuation ofatrial fibrillation.

At step 1044, the heart is artificially stimulated based on the actuallocation determined by the first signal array to generate a secondsignal array. The heart can be artificially stimulated by any suitabledevice known in the art. The second signal array can include theelectrical activation sequence taken at the predicted foci and recordedby the locator assembly during a clinical episode of atrial fibrillationof the patient.

At step 1046, the second signal array is superimposed over the firstsignal array. The superimposition of the signal array data can becompleted in the same and/or a similar manner as the embodimentsillustrated in FIGS. 8-9 . In some embodiments, the step ofsuperimposing can be displayed on a graphical user interface (GUI) on anexternal device.

At step 1048, the superimposed signal arrays are compared. If the signalarrays match, the method proceeds to step 1050. If the signal arrays arenot matched, the method restarts at step 1040.

At step 1050, the actual location of arrhythmogenic foci is confirmed,and the method for determining the location of arrhythmogenic foci in ornear the heart is completed.

FIG. 11 is a flow chart outlining one embodiment of a method fordetermining the location of arrhythmogenic foci in the heart. It isunderstood that the method pursuant to the disclosure herein can includegreater or fewer steps than those shown and described relative to FIG.11 . The method can omit one or more steps illustrated in FIG. 11 . Themethod can add additional steps not shown and described in FIG. 11 , andstill fall within the purview of the present invention. Further, thesequence of the steps can be varied from those shown and describedrelative to FIG. 11 . The sequence of steps illustrated in FIG. 11 isnot intended to limit the sequencing of steps in any manner.

In the embodiment illustrated in FIG. 11 , at step 1152, a locatorassembly is positioned within the heart. The locator assembly caninclude a plurality of electrodes that receive electrical signals fromthe heart. However, other designs of locator assemblies can be used withthe methods described herein.

At step 1154, a first signal array is generated from the electricalsignals received by the locator assembly to determine an actual locationof the arrhythmogenic foci.

At step 1156, the heart is artificially stimulated based on the actuallocation determined by the first signal array to generate a secondsignal array. The heart can be artificially stimulated by any suitabledevice known in the art.

At step 1158, the second signal array is superimposed over the firstsignal array. The superimposition of the signal data can be the sameand/or similar to the embodiments illustrated in FIGS. 8-9 . In someembodiments, the step of superimposing can be displayed on a graphicaluser interface (GUI) on an external device.

At step 1160, the superimposed signal arrays are compared. If the signalarrays match, the method proceeds to step 1162. If the signal arrays arenot matched, the method restarts at step 1156.

At step 1162, the actual location of arrhythmogenic foci is confirmed,and the method for determining the location of arrhythmogenic foci in ornear the heart is completed.

FIG. 12 is a flow chart outlining one embodiment of a method fordetermining the location of arrhythmogenic foci in the heart. It isunderstood that the method pursuant to the disclosure herein can includegreater or fewer steps than those shown and described relative to FIG.12 . The method can omit one or more steps illustrated in FIG. 12 . Themethod can add additional steps not shown and described in FIG. 12 , andstill fall within the purview of the present invention. Further, thesequence of the steps can be varied from those shown and describedrelative to FIG. 12 . The sequence of steps illustrated in FIG. 12 isnot intended to limit the sequencing of steps in any manner.

In the embodiment illustrated in FIG. 12 , at step 1264, a locatorassembly is positioned within the heart. The locator assembly caninclude a plurality of electrodes that receive electrical signals fromthe heart. However, other designs of locator assemblies can be used withthe methods described herein.

At step 1266, a first signal array is generated from the electricalsignals received by the locator assembly.

At step 1268, an actual location of the arrhythmogenic foci isdetermined.

At step 1270, the heart is artificially stimulated based on the actuallocation determined by the first signal array to generate a secondsignal array. The heart can be artificially stimulated by any suitabledevice known in the art.

At step 1272, at least one of the first and second signals array isprocessed with a processor.

At step 1274, the first signal array and the second signal array aresuperimposed.

At step 1276, the superimposed signal arrays are displayed on agraphical user interface. The superimposition of the signal data can bethe same and/or similar to the embodiments illustrated in FIGS. 8-9 .

At step 1278, the actual location of the arrhythmogenic foci isconfirmed using the superimposed signal arrays.

The present technology provides a system, device, and method fordetermining the location of arrhythmogenic foci. The locator assemblycan utilize protective materials such as inner/outer layers and canimplement drug elution. The eluted drug is released over time tocounteract the pro-thrombotic and inflammatory potential by the inflatedlocator assembly at its final location. Additionally, the presenttechnology provides a safe housing between the inner and outer layer tohost the various elements (integrated circuits, routing layers, battery,antenna) that compose the locator assembly.

It is appreciated that the system, device, and method provided hereinaddress multiple potential issues with the performance, reliability, andproper usage of deliverable locator assemblies, in particular locatorassemblies that utilize a plurality of bipolar electrodes to determinethe location of the focal point of atrial fibrillation. Specificproblems solved by the system, device, and method disclosed hereininclude:

-   1) The technology disclosed herein improves the deliverable locator    technology to enable mapping of precipitating episodes of clinical    atrial fibrillation during the patient’s daily life;-   2) The technology disclosed herein increases the accuracy of the    determination of the location of the focal point of atrial    fibrillation;-   3) The technology disclosed herein reduces the time to determine the    location of the focal point of atrial fibrillation;-   4) The technology disclosed herein provides recharging capabilities    for the locator assembly while implanted within the patient; and-   5) The technology disclosed herein reduces the risk of thrombus    formation and wall bleeding upon delivery and removal of the locator    assembly.

It should be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the content and/or context clearly dictates otherwise. It shouldalso be noted that the term “or” is generally employed in its sense,including “and/or” unless the content or context clearly dictatesotherwise.

It should also be noted that, as used in this specification and theappended claims, the phrase “configured” describes a system, apparatus,or other structure that is constructed or configured to perform aparticular task or adopt a particular configuration. The phrase“configured” can be used interchangeably with other similar phrases suchas arranged and configured, constructed and arranged, constructed,manufactured and arranged, and the like.

The headings used herein are provided for consistency with suggestionsunder 37 CFR 1.77 or otherwise to provide organizational cues. Theseheadings shall not be viewed to limit or characterize the invention(s)set out in any claims that may issue from this disclosure. As anexample, a description of a technology in the “Background” is not anadmission that technology is prior art to any invention(s) in thisdisclosure. Neither is the “Summary” or “Abstract” to be considered as acharacterization of the invention(s) set forth in issued claims.

The embodiments described herein are not intended to be exhaustive or tolimit the invention to the precise forms disclosed in the detaileddescription provided herein. Rather, the embodiments are chosen anddescribed so that others skilled in the art can appreciate andunderstand the principles and practices. As such, aspects have beendescribed with reference to various specific and preferred embodimentsand techniques. However, it should be understood that many variationsand modifications may be made while remaining within the spirit andscope herein.

It is understood that although a number of different embodiments ofsystems, devices, and methods for determining the location ofarrhythmogenic foci have been illustrated and described herein, one ormore features of any one embodiment can be combined with one or morefeatures of one or more of the other embodiments, provided that suchcombination satisfies the intent of the present invention.

While a number of exemplary aspects and embodiments of the systems,devices, and methods for determining the location of arrhythmogenic focihave been discussed above, those of skill in the art will recognizecertain modifications, permutations, additions, and sub-combinationsthereof. It is therefore intended that the following appended claims andclaims hereafter introduced are interpreted to include all suchmodifications, permutations, additions, and sub-combinations as arewithin their true spirit and scope, and no limitations are intended tothe details of construction or design herein shown.

1. A locator assembly for determining a location of an arrhythmogenicfoci in or near a heart, the locator assembly comprising: a device body;and a plurality of electrodes that receive electrical signals from theheart to determine the location of the arrhythmogenic foci, theplurality of electrodes being coupled to the device body.
 2. The locatorassembly of claim 1 wherein at least two of the plurality of electrodesare positioned longitudinally about the device body.
 3. The locatorassembly of claim 1 wherein at least two of the plurality of electrodesare positioned circumferentially about the device body.
 4. The locatorassembly of claim 2 wherein at least two of the plurality of electrodesare positioned circumferentially about the device body.
 5. The locatorassembly of claim 1 wherein the plurality of electrodes includes aplurality of anodes and cathodes that form a plurality of bipoles. 6.The locator assembly of claim 1 further comprising a routing layer thatpositions the plurality of electrodes relative to the device body, therouting layer being flexible.
 7. The locator assembly of claim 1 whereinthe plurality of electrodes that are configured to receive electricalsignals from the heart.
 8. The locator assembly of claim 1 wherein theplurality of electrodes are evenly spaced apart from one another about acircumference of the device body.
 9. The locator assembly of claim 1wherein the plurality of electrodes includes at least 12 electrodes. 10.The locator assembly of claim 1 wherein the plurality of electrodes arepositionable in direct contact with the heart.
 11. A locator assemblyfor determining a location of an arrhythmogenic foci in or near a heart,the locator assembly comprising: a device body; and a plurality ofelectrodes that receive electrical signals from the heart to determinethe location of the arrhythmogenic foci, the plurality of electrodesbeing coupled to the device body, at least two of the plurality ofelectrodes being positioned circumferentially about the device body, theplurality of electrodes being positionable so that the plurality ofelectrodes are in electrical communication with the heart.
 12. Thelocator assembly of claim 11 wherein the plurality of electrodesincludes a plurality of anodes and cathodes that form a plurality ofbipoles.
 13. The locator assembly of claim 11 further comprising arouting layer that positions the plurality of electrodes, the routinglayer being flexible.
 14. The locator assembly of claim 11 wherein atleast two of the plurality of electrodes are positionedcircumferentially about the device body and at least two of theplurality of electrodes are positioned longitudinally about the devicebody.
 15. The locator assembly of claim 11 wherein the plurality ofelectrodes include an electrocardiogram electrode.
 16. The locatorassembly of claim 11 wherein the plurality of electrodes arepositionable in direct contact with the heart.
 17. The locator assemblyof claim 11 wherein the plurality of electrodes includes at least 12electrodes.
 18. The locator assembly of claim 11 wherein the pluralityof electrodes includes at least 16 electrodes that form at least 28bipoles.
 19. The locator assembly of claim 11 wherein the plurality ofelectrodes are evenly radially spaced apart from one another about acircumference of the device body.
 20. A locator assembly for determininga location of an arrhythmogenic foci in or near a heart, the locatorassembly comprising: a device body that includes a circumference; and aplurality of electrodes that receive electrical signals from the heartto determine the location of the arrhythmogenic foci, the plurality ofelectrodes being coupled to the device body, the plurality of electrodesbeing configured to record electrical signals from the heart, each ofthe plurality of electrodes being evenly spaced apart from one anotherabout the circumference, the plurality of electrodes including at least16 electrodes that form at least 28 bipoles.